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Trial record 1 of 1 for:    NCT02776644
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Clinical Outcome Of Advanced Renal Cell Carcinoma In Taiwan

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ClinicalTrials.gov Identifier: NCT02776644
Recruitment Status : Completed
First Posted : May 18, 2016
Results First Posted : April 29, 2019
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date May 11, 2016
First Posted Date May 18, 2016
Results First Submitted Date December 24, 2018
Results First Posted Date April 29, 2019
Last Update Posted Date April 29, 2019
Actual Study Start Date October 15, 2016
Actual Primary Completion Date December 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 23, 2019)
  • Duration of Sunitinib and Pazopanib Treatment in Participants [ Time Frame: during the observation period of 11 years ]
    Treatment durations (in days) of Sunitinib and Pazopanib were calculated from the date of the first prescription to the last dose of Sunitinib and Pazopanib during the 11 year observation period.
  • Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From the Time of Start of Treatment Up to Month 3 [ Time Frame: from the time of start of treatment up to Month 3 ]
    The cumulative number of Sunitinib and Pazopanib capsules which were given to the participants from the time of start of treatment up to Month 3 were reported here.
  • Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From Month 3 to Month 6 [ Time Frame: Month 3 up to Month 6 ]
    The cumulative number of Sunitinib and Pazopanib capsules which were given to the participants from Month 3 (after the start of treatment) to Month 6 were reported here.
  • Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From Month 6 to Month 9 [ Time Frame: Month 6 up to Month 9 ]
    The cumulative number of Sunitinib and Pazopanib capsules which were given to the participants from Month 6 (after the start of treatment) to Month 9 were reported here.
  • Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From Month 9 to Month 12 [ Time Frame: Month 9 up to Month 12 ]
    The cumulative number of Sunitinib and Pazopanib capsules which were given to the participants from Month 9 (after the start of treatment) to Month 12 were reported here.
  • Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From the Time of Start of Treatment Up to Month 12 [ Time Frame: from the time of start of treatment up to Month 12 ]
    The cumulative number of Sunitinib and Pazopanib capsules which were given to the participants from the time of start of treatment to Month 12 were reported here.
  • Overall Renal Cell Carcinoma (RCC) Related Direct Medical Cost From the Diagnosis Date to the First Dose of Sunitinib and Pazopanib [ Time Frame: from the time of disease diagnosis till the first dose of Sunitinib and Pazopanib ]
    Direct medical costs include the cost of the Sunitinib or Pazopanib and all follow-up costs for other medication and health care interventions in ambulatory, inpatient, and nursing care. All specialist and general practitioner care, including emergency care, as well as rehabilitation and physiotherapy.
  • Overall Renal Cell Carcinoma (RCC) Related Direct Medical Cost From the First Dose of the Sunitinib and Pazopanib to the End of Observation Period [ Time Frame: From first dose of drug to the end of observation period (up to 11 years) ]
    Direct medical costs include the cost of the Sunitinib or Pazopanib and all follow-up costs for other medication and health care interventions in ambulatory, inpatient, and nursing care. All specialist and general practitioner care, including emergency care, as well as rehabilitation and physiotherapy.
  • Overall Survival [ Time Frame: from the time of first prescription of Sunitinib or Pazopanib till date of death (during the observation period of 11 years) ]
    Overall survival of participants was defined as time (in days) between date of prescribing treatment (Sunitinib or Pazopanib) till date of death.
  • Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 1 [ Time Frame: time of first dose of the drug, Month 1 ]
    Changes in the prescription patterns of antihypertensive medication were categorized as: 1) Unchanged: no change in the count/number of capsules or class(es) of the antihypertensive medication at Month 1 as compared to the time of first dose, 2) Increased: increase in counts/number of capsules of the ongoing class(es) of the antihypertensive medication at Month 1 as compared to the time of first dose, 3) Decreased: Decrease in the counts/number of capsules of ongoing class(es) of antihypertensive medication at Month 1 as compared to the time of first dose, 4) Switched: shifted to other class(es) of antihypertensive medication without changes in counts of antihypertensive medication at Month 1 as compared to the time of first dose. The number of participants with change in prescription patterns based on the specified categories is reported.
  • Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 3 [ Time Frame: time of first dose of the drug, Month 3 ]
    Changes in the prescription patterns of antihypertensive medication were categorized as: 1) Unchanged: no change in the count/number of capsules or class(es) of the antihypertensive medication at Month 3 as compared to the time of first dose, 2) Increased: increase in counts/number of capsules of the ongoing class(es) of the antihypertensive medication at Month 3 as compared to the time of first dose, 3) Decreased: Decrease in the counts/number of capsules of ongoing class(es) of antihypertensive medication at Month 3 as compared to the time of first dose, 4) Switched: shifted to other class(es) of antihypertensive medication without changes in counts of antihypertensive medication at Month 3 as compared to the time of first dose. The number of participants with change in prescription patterns based on the specified categories is reported.
  • Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 6 [ Time Frame: the first dose of the drug, Month 6 ]
    Changes in the prescription patterns of antihypertensive medication were categorized as: 1) Unchanged: no change in the count/number of capsules or class(es) of the antihypertensive medication at Month 6 as compared to the time of first dose, 2) Increased: increase in counts/number of capsules of the ongoing class(es) of the antihypertensive medication at Month 6 as compared to the time of first dose, 3) Decreased: Decrease in the counts/number of capsules of ongoing class(es) of antihypertensive medication at Month 6 as compared to the time of first dose, 4) Switched: shifted to other class(es) of antihypertensive medication without changes in counts of antihypertensive medication at Month 6 as compared to the time of first dose. The number of participants with change in prescription patterns based on the specified categories is reported.
  • Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 12 [ Time Frame: the first dose of the medication, Month 12 ]
    Changes in the prescription patterns of antihypertensive medication were categorized as: 1) Unchanged: no change in the count/number of capsules or class(es) of the antihypertensive medication at Month 12 as compared to the time of first dose, 2) Increased: increase in counts/number of capsules of the ongoing class(es) of the antihypertensive medication at Month 12 as compared to the time of first dose, 3) Decreased: Decrease in the counts/number of capsules of ongoing class(es) of antihypertensive medication at Month 12 as compared to the time of first dose, 4) Switched: shifted to other class(es) of antihypertensive medication without changes in counts of antihypertensive medication at Month 12 as compared to the time of first dose. The number of participants with change in prescription patterns based on the specified categories is reported.
  • Number of Participants Who Received Antihypertensive Medication at Baseline [ Time Frame: Baseline (at the beginning of 11 year observation period) ]
    To calculate number of patient receiving antihypertensive prescriptions at baseline for each TKI users and classify the patterns of changes into unchanged, switched, increased and decreased. Shifting to other class(es) of antihypertensive agents without changes in counts of antihypertensive medication is defined as being switched.
  • Number of Participants Who Received Antihypertensive Medication From Baseline to Month 1 [ Time Frame: Baseline (at the beginning of 11 year observation period) up to Month 1 ]
    To calculate number of patient receiving antihypertensive prescriptions at Month 1 for each TKI users and classify the patterns of changes into unchanged, switched, increased and decreased. Shifting to other class(es) of antihypertensive agents without changes in counts of antihypertensive medication is defined as being switched.
  • Number of Participants Who Received Antihypertensive Medication From Month 1 to Month 3 [ Time Frame: Month 1 up to Month 3 since Sunitinib or Pazopanib initiation (during the observation period of 11 years) ]
    To calculate number of patient receiving antihypertensive prescriptions from Month 1 to Month 3 for each TKI users and classify the patterns of changes into unchanged, switched, increased and decreased. Shifting to other class(es) of antihypertensive agents without changes in counts of antihypertensive medication is defined as being switched.
  • Number of Participants Who Received Antihypertensive Medication From Month 3 to Month 6 [ Time Frame: Month 3 up to Month 6 since Sunitinib or Pazopanib initiation (during the observation period of 11 years) ]
    To calculate number of patient receiving antihypertensive prescriptions from Month 3 to Month 6 for each TKI users and classify the patterns of changes into unchanged, switched, increased and decreased. Shifting to other class(es) of antihypertensive agents without changes in counts of antihypertensive medication is defined as being switched.
  • Number of Participants Who Received Antihypertensive Medication From Month 6 to Month 12 [ Time Frame: Month 6 up to Month 12 since Sunitinib or Pazopanib initiation (during the observation period of 11 years) ]
    To calculate number of patient receiving antihypertensive prescriptions from Month 6 to Month 12 for each TKI users and classify the patterns of changes into unchanged, switched, increased and decreased. Shifting to other class(es) of antihypertensive agents without changes in counts of antihypertensive medication is defined as being switched.
Original Primary Outcome Measures
 (submitted: May 17, 2016)
Change of dosage pattern of systemic therapies [ Time Frame: From baseline up to 12 months ]
The dosage pattern change of systemic therapies for advanced renal cell carcinoma with routine practice in Taiwan.
Change History Complete list of historical versions of study NCT02776644 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: May 17, 2016)
  • duration of systemic treatments [ Time Frame: base line up to 12 months ]
    duration of systemic treatments on targeted therapy agent for advanced renal cell carcinoma
  • treatment cost [ Time Frame: base line up to 12 months ]
    treatment cost for advanced renal cell carcinoma
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Outcome Of Advanced Renal Cell Carcinoma In Taiwan
Official Title CLINICAL OUTCOME OF ADVANCED RENAL CELL CARCINOMA IN TAIWAN, A RETROSPECTIVE NHIA DATABASE ANALYSIS
Brief Summary The clinical outcome of advanced / metastatic renal cell carcinoma has been changed since targeted therapy being widely applied. This study will retrospectively analyse the clinical outcome of advanced renal cell carcinoma captured in Taiwan National Health Insurance Research Database.
Detailed Description Targeted therapy agents have significantly changed the clinical outcome of advanced / metastatic renal cell carcinoma. However, the dosing pattern varied and might result in impact to duration of treatment. In Taiwan, National Health Insurance system has a coverage more than 90% of population and thus can serve as an appropriate database for further analysis on Taiwanese advanced renal cell carcinoma. This study will retrospectively analyse the clinical outcome of advanced renal cell carcinoma captured in Taiwan National Health Insurance Research Database.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population advanced/metastatic renal cell carcnioma
Condition Renal Cell Carcinoma
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 23, 2019)
1349
Original Enrollment Not Provided
Actual Study Completion Date December 30, 2017
Actual Primary Completion Date December 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • advanced/metastatic renal cell carcinoma

Exclusion Criteria:

  • N/A
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02776644
Other Study ID Numbers A6181222
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2019